Manufacturing Engineer II- 2nd Shift

Nextern•Maple Grove, MN

4d•Onsite

About The Position

The Manufacturing Quality Engineer ensures that manufacturing programs meet applicable quality, regulatory, and customer requirements by providing quality oversight, driving compliant execution, and supporting continuous improvement across the product lifecycle. This role provides operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Manufacturing Quality Engineers also support development activities as programs prepare to launch into commercial manufacturing, including manufacturing readiness, audits, and clinical builds. This support helps ensure a smooth transition while maintaining accurate and compliant Design History Files. All engineering functions are responsible for compliance with the Quality System and applicable regulations and standards, continuous improvement, and professional interaction with Nextern customers, as needed.

Requirements

Bachelor’s degree in a life science discipline, or an equivalent combination of education and experience.
5+ years of experience in medical device development or manufacturing, or 3+ years of experience in a Design Assurance or Quality Engineering role.
Experience working within quality systems defined by 21 CFR Part 820 and ISO 13485.
Demonstrated technical expertise and leadership in quality.
High attention to detail, organization, and accuracy.
Demonstrated ability to think creatively and propose practical, novel solutions.
Strong ability to communicate in writing and verbally within and across disciplines and organizational structures.

Responsibilities

Serve as a project core team member accountable for operations quality deliverables.
Author and approve SOPs, work instructions, and forms.
Support internal audits and maintain inspection readiness across the quality system.
Compile and trend quality metrics to identify systemic issues.
Present actionable insights to leadership and drive implementation of corrective and preventive actions.
Oversee incoming inspection report approval.
Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
Provide quality oversight for IQ/OQ/PQ qualification activities.
Review and approve protocols, reports, and change orders.
Evaluate regulatory impact of equipment changes prior to implementation.
Manage nonconformances and CAPAs from initiation through effectiveness verification.
Lead root cause analysis using structured methods (5-Why, fishbone).
Trend data and report findings at management review.
Act as the quality point of contact for production; review batch records and travelers for GMP compliance; support line clearances, first-article inspections, and process change reviews.
Draft, collaborate, and approve product and engineering work orders.
Create and maintain up-to-date product Design History Files (DHF).
Advise project teams and lead by example in best practices for Quality and Regulatory Compliance.
Own, review, and approve changes to ensure impacts and resulting action or implementation decisions are properly documented and executed.
Receive, investigate, and document product complaints, interacting with customers as applicable.
Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs.
Drive Product Lifecycle Management (PLM) architecture and changes, as needed.
Perform other tasks as deemed necessary.